Transcatheter Aortic Valve ReplacementCara CDRMNCT05465655
Cara CDRM (Conduction Disturbance Risk Monitor) 2.0
A study testing ECG monitoring for Conduction Disturbances in people with Transcatheter Aortic Valve Replacement, run by Cara Medical Ltd at 1 site in United States.
Trial summary
Prospective, multicenter, roll-in, pilot clinical trial. Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- ECG monitoring for Conduction Disturbances
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet be ≥ 18 years of age.
- Must meet indications for TAVR using approved devices
- Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Willing to comply with specified follow-up evaluations.
- Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.
Who cannot join
- Any implanted device or an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
- Any contraindication to the TAVR procedure according to the instructions for use.
- Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
- Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Estimate a Reduction of TAVR Associated Conduction Disturbance Through Notification of Cara Monitor During TAVR Procedure
Prospective, multicenter, roll-in, pilot clinical trial.
Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD).
Read more
The study will be conducted in two stages:
During the first roll-in stage of the study, 50 intended to undergo TAVR (all comers) will be enrolled.
Data will be collected according to the study schedule below of pre-, during and after the TAVR procedure up to 14 days FU.
This data for the first 50 patients will be analyzed to evaluate the ability of the Cara Monitor prediction of NOCD post TAVR.
The second stage of the stage will be conducted upon completion of the first stage analysis and will be considered to randomize 1:1 the subjects connected to Cara Monitor during the procedure versus site-specific current practice.
The effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice will be estimated.
Read the detailed description
Data to be collected during the study procedure for both stages:
- Pre-procedure:
- Demographics, medical history, cardiac history, medications
- Cardiac CT raw data to be collected from all the pre-procedure CT scans performed in Medical Centers and from out-of-hospital sources (if available).
- In hospital 12 lead ECG
- Procedure: During the procedure, the 12 lead ECG will be recorded processed, and displayed on the Cara monitor that is connected to Norav NR-1207-3 ECG Holter System. The Hemodynamic and Fluoroscopy monitors will be recorded on a commercially available video recorder.
- Post-procedure (in hospital)
- After the procedure patients will continue to be connected to a commercially available to a commercially available 14 days ambulatory Holter monitor (AEM) (e.g. Bittium Faros™ ; MoMe™ Kardia) and will remain with the patient after the discharge for 14 days.
- Hospital standard 12 lead ECG will be recorded after the procedure, downloaded and collected by the study team.
- Post-procedure - out of hospital: At discharge, patients will stay connected to the ambulatory Holter monitor (AEM) (Bittium Faros™; MoMe™ Kardia ) for 14 days post-procedure. Holter will be collected from patients at the end of the 14-day recording and its data downloaded and collected. Patients will be followed according to the current medical practice.
- Follow-up according to the current medical practice a. 30 days follow-up hospital visit: i. Cardiac echo (if available) ii. 12 lead ECG b. 6 month - Clinical FU phone call c. 12 months Clinical FU phone call
Conduction Disturbances (CD) outcome will be subdivided into:
- PPM or High-Grade AV Block (HGAVB)
- All other new onset (or deterioration) of CD that are not listed in #1
- No new onset CD
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- ECG monitoring for Conduction Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoring for Conduction DisturbancesOther
Also called Continues ECG monitoring
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TAVR | Experimental | Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed notifying for New-Onset Conduction Disturbances (NOCD) using Cara Monitor. Receives: Other: ECG monitoring for Conduction Disturbances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)
Estimate the reduction of NOCD (percentage) at 14 days post TAVR while using Cara Monitor
Measured: 14 days
Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB)
Estimate the reduction (a percentage) of PPM or High-Grade AV Block (HGAVB)
Measured: 14 days
Evaluate Cara usability using a dedicated questioner
Estimate learning curve of using CaraTM system (e.g. the experience required with system for achieving above improvements)
Measured: 1 Day of Procedure
Evaluate Cara Safety, collecting Adverse Events
During the study patients will be followed for any adverse events relevant to the TAVR procedure as defined in the CRF
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start9 Sep 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Grinberg, PhD, Study chair, Cara Medical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465655
- Sponsor's protocol ID
- Cara 2.0
- Acronym
- Cara CDRM
- Status last verified
- Aug 2023
- First submitted
- 15 Jul 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Estimate a Reduction of TAVR Associated Conduction Disturbance Through Notification of Cara Monitor During TAVR Procedure
- ClinicalTrials.gov ID
- NCT05465655
- Acronym / sponsor ID
- Cara CDRM / Cara 2.0
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cara Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, roll-in, pilot clinical trial.
Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD).
The study will be conducted in two stages:
During the first roll-in stage of the study, 50 intended to undergo TAVR (all comers) will be enrolled.
Data will be collected according to the study schedule below of pre-, during and after the TAVR procedure up to 14 days FU.
This data for the first 50 patients will be analyzed to evaluate the ability of the Cara Monitor prediction of NOCD post TAVR.
The second stage of the stage will be conducted upon completion of the first stage analysis and will be considered to randomize 1:1 the subjects connected to Cara Monitor during the procedure versus site-specific current practice.
The effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice will be estimated.
Detailed description
Data to be collected during the study procedure for both stages:
- Pre-procedure:
- Demographics, medical history, cardiac history, medications
- Cardiac CT raw data to be collected from all the pre-procedure CT scans performed in Medical Centers and from out-of-hospital sources (if available).
- In hospital 12 lead ECG
- Procedure: During the procedure, the 12 lead ECG will be recorded processed, and displayed on the Cara monitor that is connected to Norav NR-1207-3 ECG Holter System. The Hemodynamic and Fluoroscopy monitors will be recorded on a commercially available video recorder.
- Post-procedure (in hospital)
- After the procedure patients will continue to be connected to a commercially available to a commercially available 14 days ambulatory Holter monitor (AEM) (e.g. Bittium Faros™ ; MoMe™ Kardia) and will remain with the patient after the discharge for 14 days.
- Hospital standard 12 lead ECG will be recorded after the procedure, downloaded and collected by the study team.
- Post-procedure - out of hospital: At discharge, patients will stay connected to the ambulatory Holter monitor (AEM) (Bittium Faros™; MoMe™ Kardia ) for 14 days post-procedure. Holter will be collected from patients at the end of the 14-day recording and its data downloaded and collected. Patients will be followed according to the current medical practice.
- Follow-up according to the current medical practice a. 30 days follow-up hospital visit: i. Cardiac echo (if available) ii. 12 lead ECG b. 6 month - Clinical FU phone call c. 12 months Clinical FU phone call
Conduction Disturbances (CD) outcome will be subdivided into:
- PPM or High-Grade AV Block (HGAVB)
- All other new onset (or deterioration) of CD that are not listed in #1
- No new onset CD
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing TAVR | Experimental | Other: ECG monitoring for Conduction DisturbancesStudy subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed notifying for New-Onset Conduction Disturbances (NOCD) using Cara Monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must meet be ≥ 18 years of age.
- Must meet indications for TAVR using approved devices
- Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Willing to comply with specified follow-up evaluations.
- Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.
Key exclusion criteria (4 listed)
- Any implanted device or an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
- Any contraindication to the TAVR procedure according to the instructions for use.
- Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
- Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoring for Conduction DisturbancesAlso: Continues ECG monitoringContinuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure | Other | Patients undergoing TAVR |
Primary outcome
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)
Time frame: 14 days
Estimate the reduction of NOCD (percentage) at 14 days post TAVR while using Cara Monitor
Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB)
Time frame: 14 days
Estimate the reduction (a percentage) of PPM or High-Grade AV Block (HGAVB)
Evaluate Cara usability using a dedicated questioner
Time frame: 1 Day of Procedure
Estimate learning curve of using CaraTM system (e.g. the experience required with system for achieving above improvements)
Evaluate Cara Safety, collecting Adverse Events
Time frame: 14 days
During the study patients will be followed for any adverse events relevant to the TAVR procedure as defined in the CRF
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
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Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Grinberg, PhD study chair
Cara Medical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG monitoring for Conduction Disturbances in people with Transcatheter Aortic Valve Replacement, run by Cara Medical Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD) (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.